SAN DIEGO, CA--(Marketwire - January 12, 2009) -
Nerveda Inc. and Aegis Therapeutics LLC today
announced preclinical results from their joint collaboration aimed at
developing non-injectable formulations of the beta-interferons. The beta
interferons, beta-1a (tradename Rebif®), and beta 1b (tradenames
Betaseron® and Betaferon®) are closely related injectable protein drugs
in the interferon family that are used to treat both the
relapsing-remitting and secondary-progressive forms of multiple sclerosis
(MS). The beta interferons are currently administered by subcutaneous
injection and have been proven clinically to slow the advance of multiple
sclerosis and reduce the frequency of attacks. Current worldwide combined
annual sales of Rebif®, Betaseron® and Betaferon® are approximately
Because proteins are large and fragile molecules, they cannot be
administered orally and are typically administered by injection. They are
often subject to instability due to aggregation of the protein molecules --
particularly upon storage and handling at non-refrigerated temperatures.
The resulting protein aggregates are more poorly absorbed into the blood
stream upon injection due to their increased size, and induce development
of circulating antibodies to interferon in patients that reduce the
effectiveness of the drug over time.
Leading medical scientists at Johns Hopkins University, expert in the
treatment of neurological diseases, in collaboration with Nerveda and Aegis
have applied Aegis' Intravail® transmucosal absorption enhancement, and
ProTek® protein stabilization technologies to address these problems and
have demonstrated for the first time that the beta interferons can be
administered intranasally to prevent nerve damage in preclinical animal
models of multiple sclerosis. In addition, the new formulations were shown
to reduce or eliminate the immunogenicity of Betaseron® and Rebif®,
administered either by injection or intranasally, while substantially
increasing stability in a stress test involving constant agitation at
elevated temperatures for extended periods of time.
Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in
the research, said, "since interferons will continue to be the foundation
of MS therapy, it is critical that non-invasive delivery options for
patients be developed." Maggio also indicated, "the reduction in
immunogenicity and the increase in stability also address a significant
unmet need of the currently available beta-interferon therapies."
Nerveda plans to begin testing the new formulation in clinical trials in
early 2009 in collaboration with clinicians and scientists at John Hopkins
University Medical Center and other sites.
* Rebif® is a registered trademark of Pfizer, Inc.
* Betaseron® is a registered trademark of Bayer Healthcare
* Betaferon® is a registered trademark of Bayer Schering Pharma AG
* Intravail® and ProTek® are registered trademarks of Aegis
About Nerveda Inc.
Nerveda is a privately funded specialty pharmaceutical and diagnostic
company focused on improving the quality of life for patients suffering
from neurodegenerative diseases and their caregivers. Nerveda supports the
clinical development of products licensed from Johns Hopkins University,
including neuroprotective compounds and stem cell therapeutics that show
promise in treating auto-immune disorders.
About Aegis Therapeutics
Aegis Therapeutics LLC is a drug delivery technology company
commercializing its patented or proprietary drug delivery and drug
formulation technologies through product-specific licenses. Our patented
Intravail® drug delivery technology enables the non-invasive delivery of
a broad range of protein, peptide and non-peptide macromolecular
therapeutics that can currently only be administered by injection. Aegis'
Intravail® absorption enhancement agents provide exceptionally high and
unmatched bioavailability performance, comparable in efficiency to
subcutaneous injection, via the intranasal administration route.
Intravail® has also been successfully applied to buccal, oral, and rectal
administration of small molecule, peptide, and nucleotide-analog type
drugs. Our patented ProTek® technology allows creation of proprietary,
easily manufacturable, and stable aqueous or lyophilized dosage forms that
maintain the integrity and physiological activity of many protein and
peptide therapeutics. ProTek® technology is applicable to injectable,
intranasal, and other dosage forms of peptide or protein therapeutics.
For more information about Aegis, please visit the Aegis website